CRO-Senior Clinical Data Manager (Sr. CDM) na LotusCR

Location: Remote

Company Website: www.lotuscr.com

Job Description:

The Senior Clinical Data Manager manages the general conduct of project assigned tasks as the Lead Data Manager or under advisement from senior members of the Data Management Team. Responsible for oversight and conducting data activities in an efficient manner and in accordance with all SOPs and regulations. Responsibilities include all data management activities, customer relationship management, development and implementation of the data correction process, discrepancy resolution, data control activities, and data validation. In addition to these standard clinical data management responsibilities, the Senior Clinical Data Manager will also assist the management team with SOP review & update, process improvement, employee onboarding, and training.

Essential Duties and Responsibilities:

• Serve as Lead or supporting Data Manager for assigned studies, overseeing data management from startup to closeout per SOPs.
• Manage protocol review, study specs, CRF and database design, edit checks, and data validation.
• Lead data cleaning, discrepancy resolution, and data transfer/control activities.
• Develop and execute Data Management Plans and ensure compliance with ICH/GCP, SOPs, and regulatory standards.
• Coordinate and conduct User Acceptance Testing for EDC systems.
• Draft & final protocol review, study specification creation, case report form design, database design/build, form and edit check programming within EDC, and review of all data management specific study documents.
• Oversee clinical trial data from setup through database lock, including regulatory submissions.
• Monitor timelines, milestones, and ensure quality through supervision and QC of team deliverables.
• Support process improvements and SOP updates.
• Collaborate with cross-functional teams and maintain vendor relationships.
• Participate as needed in reviewing and responding to QA audit reports. 
• Participate in audits, sponsor meetings, and departmental initiatives.
• Train and mentor junior staff; assist other Data Managers as needed.
• Maintain key vendor relationships such as EDC System Vendor, etc.
• Perform additional duties as required.

Education and/or Experience:

• MS/MA in health science, life science, information technology, or nursing AND 6 years equivalent experience OR demonstrated aptitude for the Senior Clinical Data Manager role. 
• Experience working in CRO industry preferred. 
• Working knowledge of EDC studies.  

Skills and Abilities:

• Excellent organizational skills. 
• Strong written and verbal communication skills. 
• Exceptional attention to detail. 
• Technology proficiency including Data Management Systems. 
• Study documentation production and maintenance, data processing, data review. 
• Knowledge of clinical research including regulatory requirement GCP/ICH Data Quality. 
• Strong interpersonal skills. 
• Strong computer skills, including Microsoft Office.